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通过美国食品药品管理局新药审批的药物(2020年2月)
MIMS医药资讯2020-04-09 09:06:13人已围观
2020年2月首次通过美国食品药品管理局新药审批的药物,包括新化学成份和新生物制剂。但未包括暂时审批的药物。药物通过新药审批后可能还需要补充申请批准。
ANJESO
Active Ingredient(s): Meloxicam
Strength: 30 mg/mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Baudax Bio, Inc.
Approval Date: 20 February 2020
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for use in adults for management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.
NEXLETOL
Active Ingredient(s): Bempedoic acid
Strength: 180 mg
Dosage Form(s) / Route(s): Tablet; oral
Company: Esperion Therapeutics, Inc.
Approval Date: 21 February 2020
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
VYEPTI
Active Ingredient(s): Eptinezumab-jjmr
Strength: 100 mg/mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Lundbeck Seattle BioPharmaceuticals, Inc.
Approval Date: 21 February 2020
Submission Classification: Not available
Indication(s): Indicated for the preventive treatment of migraine in adults.
BARHEMSYS
Active Ingredient(s): Amisulpride
Strength: 5 mg/2 mL (2.5 mg/mL)
Dosage Form(s) / Route(s): Injectable; injection
Company: Acacia Pharma, Ltd.
Approval Date: 26 February 2020
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated in adults for:
Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class of have not received prophylaxis.
NEXLIZET
Active Ingredient(s): Bempedoic acid; ezetimibe
Strength: 180 mg/10 mg
Dosage Form(s) / Route(s): Tablet; oral
Company: Esperion Therapeutics, Inc.
Approval Date: 26 February 2020
Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
Indication(s): Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular diseae who require additional lowering of LDL-C.
NURTEC ODT
Active Ingredient(s): Rimegepant
Strength: 75 mg
Dosage Form(s) / Route(s): Tablet, orally disintegrating; oral
Company: Biohaven Pharma Holding Co., Ltd.
Approval Date: 27 February 2020
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
PIZENSY
Active Ingredient(s): Lactitol monohydrate (BLI400)
Strength: 10 g; 20 g
Dosage Form(s) / Route(s): Solution; oral
Company: Braintree Labs
Approval Date: 12 February 2020
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
PEMFEXY
Active Ingredient(s): Pemetrexed
Strength: 25 mg/mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Eagle Pharms
Approval Date: 08 February 2020
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for:
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC).
as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progresses after four cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
in combination with cisplatin for the initial treatment, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
TWIRLA
Active Ingredient(s): Levonorgestrel; ethinyl estradiol
Strength: 120 mcg; 30 mcg
Dosage Form(s) / Route(s): System; transdermal
Company: Agile Therapeutics, Inc.
Approval Date: 14 February 2020
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
PROCYSBI
Active Ingredient(s): Cysteamine bitartrate
Strength: 75 mg; 300 mg
Dosage Form(s) / Route(s): Granule, delayed release; oral
Company: Horizon Pharma USA
Approval Date: 14 February 2020
Submission Classification: Not available
Indication(s): Indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.
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